Randomization & Trial Supply Management
Innovative Randomization and Trial Supply Management System (RTSM)
THE ONLY BIOSTATISTICS-DRIVEN RTSM
Sponsors use ID-net™ to monitor patient recruitment in real time, while investigators use the same Internet platform to allocate treatments to patients in clinical trials.
Based on the latest IT technology, and seamlessly integrated with our EDC system, ID-net™ the IDDI Randomization and Trial Supply Management System (RTSM) platform is highly configurable, allowing a fast set-up of critical features such as randomization, treatment allocation and trial supply inventory.
KEY BENEFITS OF ID-net – IDDI RANDOMIZATION & TRIAL SUPPLY MANAGEMENT (RTSM)
- Timelines ranging from 4 to 8 weeks
- Randomization without Trial Supply: 4 weeks
- Randomization with trial supply: 8 weeks
- Fast implementation of protocol amendments.
- Adjustable throughout the study with no downtime
- Provides real-time information to Sponsors, Monitors, Investigators and all trial participants
BIOSTATISTICS DRIVEN RTSM
- In-house biostatisticians & Randomization Teams to provide the most appropriate randomization methodology & follow-up
- Stratified randomization using dynamic or static schemes
- Permuted block,
- Adaptive designs
SUPPORTS ALL TYPES OF RANDOMIZATION SCHEMES
- Fixed, dynamic, multi-stage, adaptive
INTEGRATED WITH EDC
- Real-time integration with IDDI EDC system (ID-base)
- Direct integration with various EDC and drug supply distributors.
- Easily plugged into any EDC.
EASY SET UP INTERFACE
- User-friendly interface on all browsers
- Compatible with tablets and Smartphones
- 21 CFR Part 11 Validated system
- Various trial supply strategies per site
- Scheduling of patient visits, single sign-on to access multiple studies, different profiles per user and per study.
KEY FEATURES OF ID-net IDDI RTSM
- Eligibility checks, patient number, screen failure tracking.
- Stratified randomization using dynamic or static schemes.
- Randomization methods: Minimization. Permuted block. Multi-stage randomization designs. Response adaptive designs. Adaptive dose-findings.
- Email confirmation.
- Blinded treatment allocations.
- Open treatment allocations.
- Dose and treatment variations.
- Emergency code breaks.
- Real time online reports for sponsor, monitors and site users.
- Scheduling of subjects and monitoring visits.
- Adaptive automatic drug supply process
- 24/7 helpdesk by IDDI employees
TRIAL SUPPLY MANAGEMENT
- Reduce wastage and costs
- Automatic trial supply management based on subject accrual and treatment
- Management of product life cycle (shipments, allocation, quarantine, tracking of damage…)
- Relabeling and management of expiry date
- Advanced inventory reports
- Trial supply tracking and inventory.
HELP FROM QUALIFIED STAFF
- Attendance to investigators meeting in person or web training.
- Study specific user manual provided to monitors and participating sites.
- Secured access only to authorized users.
- TLS and data encryption from the server.
- Secure servers and mirrored systems with on-site and off-site backup
- Full audit trail.